传染病防控药品之不良反应的救济制度建构  

On the Construction of Relief System for Adverse Drug Reactions Caused by Infectious Diseases Prevention and Control

作　　者：邵华[1] 张苑晖 Shao Hua;Zhang Yuanhui

机构地区：[1]中南大学法学院

出　　处：《医学与法学》2021年第4期32-41,共10页Medicine and Jurisprudence

基　　金：湖南省研究生科研创新项目“我国大规模药品损害救济机制研究”(项目编号:CX20190168);中南大学中央高校基本科研业务费专项资金资助项目“我国大规模药品损害救济机制研究”(项目编号:2019zzts112)的阶段性成果。

摘　　要：药品不良反应不仅涉及个体损害,还可能对一国公共卫生安全产生重大影响,在某种程度上其已进入公益视野;而与普通治疗用药相比,传染病防控用药有更多特殊之处,新规则的出现、患者自主决定权受限及用药情况的复杂性等,使传染病防控所引发的药品不良反应救济变成一个公共问题。司法实践中,有患者以侵权诉讼的方式、公平的名义,试在医院、药企和个人之间分担风险来寻求救济,但此方式随着《民法典》对公平分担损失适用方式的修订已难以为继。为维护、实现公民的健康平等,对遭遇药品不良反应的患者,建议建构以国家补偿义务为基础的直接救济机制:以传染病防治法修订为契机,建立我国传染病防控药品不良反应受害者直接补偿制度,采用财政转移支付和公共保险的方式双线筹资,确立适当补偿的原则。Adverse drug reactions not only involve individual damage,but also may have a significant impact on a country's public health security,and it has entered the perspective of public welfare.Compared with the gener⁃al therapeutic drug,infectious disease treatment drug has more special features.The emergence of new rules,the limitation of patients'autonomous decision-making right,and the complexity of drug use make the relief of adverse drug reaction become a public problem.In judicial practice,some patients try to seek relief by sharing risks be⁃tween hospitals,pharmaceutical companies and individuals in the name of fairness in tort litigation,but with the re⁃vision of the application of fair loss sharing in Civil Code,this method has become unsustainable.To realize the equality of citizen's health maintenance,for those patients suffering adverse drug reactions,it is suggested that we construct direct relief mechanism based on state compensation obligation,establish adverse drug reactions victim compensation system directly in infectious diseases prevention and control in China by taking the revision on the pre⁃vention and control of infectious diseases as an opportunity,raise capital by the way of fiscal transfer payment and public insurance,and establish the principle of appropriate compensation.

关 键 词：直接救济 补偿 公平分担 公共保险 

分 类 号：D922.16[政治法律—宪法学与行政法学]